Latitude EV Total Elbow Arthroplasty

Latitude EV Total Elbow Arthroplasty is an FDA 510(k)-cleared medical device (K171010) manufactured by Tornier, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 30, 2017. Regulation: 8.